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Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) (HLSSM)

Primary Purpose

Shoulder Impingement Syndrome, Adhesive Capsulitis, Rotator Cuff Tear

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management
Sponsored by
Issa, Abdulhamid Sayed, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Shoulder, Shoulder approach, Lateral Shoulder approach, Shoulder impingement syndrome, Rotator cuff tendinopathy, Adhesive capsulitis, Frozen shoulder syndrome, MLSA, Shoulder arthroscopy, Mini Lateral Shoulder Approach, Second Sayed Issa's Approach, Hill-sachs lesion, mini-incision release, Tendinopathy, arthroscopy, tendon injuries

Eligibility Criteria

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Inclusion Criteria: Patients presented with Shoulder Impingement Syndrome refractory to conservative treatment and local steroid injection Patients presented with Adhesive Capsulitis and Frozen Shoulder Syndrome refractory to conservative treatment and local steroid injection Patients without femur head immigration on X-ray Patients with injury for one month to six months maximum Exclusion Criteria: Patients with femur head immigration on X-ray Patients with injury for more than six months Uncontrolled diabetes mellitus type 1 and 2 Patients with non controlled Vascular hypertension Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization

Sites / Locations

  • Dr. Abdulhamid Sayed Issa Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Issa3

Arm Description

Dr.A.Sayed Issa and his team

Outcomes

Primary Outcome Measures

Less open surgery trauma
Directly going to the goal lesion with less expansion

Secondary Outcome Measures

Smaller surgical incision than MLSA
Directly going to the goal lesion

Full Information

First Posted
May 12, 2023
Last Updated
June 23, 2023
Sponsor
Issa, Abdulhamid Sayed, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT05897866
Brief Title
Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM)
Acronym
HLSSM
Official Title
Sayed Issa's Hybrid Limited Shoulder Surgical Management (HLSSM)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
May 12, 2023 (Actual)
Study Completion Date
May 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Issa, Abdulhamid Sayed, M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) is a limited lateral approach to the shoulder arthroscopically guided. Which achieves less surgical trauma and smaller surgical incision than even in Mini Lateral Shoulder Approach (MLSA).
Detailed Description
After making a full clinical, X-rays and MRI examinations of the shoulder, and finding Shoulder Impingement Syndrome, Adhesive Capsulitis, Rotator Cuff Tear, or Hill-Sachs lesion, we decide to manage the problem surgically We can survey the shoulder from the inside and determine the shape, size and the exact position of the defect by shoulder arthroscopy. The patient is operated on under general anesthesia; shoulder arthroscopy can be performed in the lateral decubitus or beach chair position which is the basic shoulder arthroscopy (Beach Chair Patient Positioning). After identifying the full characteristics of the lesion, we go for Mini Lateral Shoulder Approach (MLSA), as known as Second Sayed Issa's Approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome, Adhesive Capsulitis, Rotator Cuff Tear, Hill-Sachs Lesion, Frozen Shoulder, Tendinopathy
Keywords
Shoulder, Shoulder approach, Lateral Shoulder approach, Shoulder impingement syndrome, Rotator cuff tendinopathy, Adhesive capsulitis, Frozen shoulder syndrome, MLSA, Shoulder arthroscopy, Mini Lateral Shoulder Approach, Second Sayed Issa's Approach, Hill-sachs lesion, mini-incision release, Tendinopathy, arthroscopy, tendon injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Issa3
Arm Type
Experimental
Arm Description
Dr.A.Sayed Issa and his team
Intervention Type
Procedure
Intervention Name(s)
Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management
Other Intervention Name(s)
Sayed Issa's HSSM
Intervention Description
Using Arthroscopy and then Limited Opening by Mini Lateral Shoulder Approach (MLSA) for the shoulder surgery.
Primary Outcome Measure Information:
Title
Less open surgery trauma
Description
Directly going to the goal lesion with less expansion
Time Frame
25 minutes to 45 minutes,
Secondary Outcome Measure Information:
Title
Smaller surgical incision than MLSA
Description
Directly going to the goal lesion
Time Frame
Less than 5 cm

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients presented with Shoulder Impingement Syndrome refractory to conservative treatment and local steroid injection Patients presented with Adhesive Capsulitis and Frozen Shoulder Syndrome refractory to conservative treatment and local steroid injection Patients without femur head immigration on X-ray Patients with injury for one month to six months maximum Exclusion Criteria: Patients with femur head immigration on X-ray Patients with injury for more than six months Uncontrolled diabetes mellitus type 1 and 2 Patients with non controlled Vascular hypertension Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
Facility Information:
Facility Name
Dr. Abdulhamid Sayed Issa Clinic
City
Aleppo
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing URL
http://www.asayedissa.com
Links:
URL
http://asayedissa.com
Description
Related Info

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Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM)

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